Stemedica Cell Technologies, Inc., a leading manufacturer of adult ischemia tolerant allogeneic stem cells and stem cell factors announced that the Company has signed an agreement with The Scripps Research Institute to investigate the role of Stemedica’s ischemia tolerant human mesenchymal stem cells and stem cell factors as a therapy for severe lung injury and sepsis.

Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) are the most common causes of respiratory failure among critically ill patients. The mortality for this syndrome remains high at 30-40% and accounts for approximately 75,000 deaths per year. Severe bacterial pneumonia is the most common cause of ALI/ARDS and is frequently associated with septic shock. The only intervention for ALI/ARDS that has resulted in a mortality benefit is low tidal volume ventilation. Despite several attempts, there have been no pharmacological agents that have reduced the morbidity or mortality from ALI/ARDS. Furthermore, treatment of bacterial pneumonia is increasingly hampered by the rapid spread of multi-drug resistant bacteria and the lack of new antimicrobial agents to treat them. Therefore, given the large public health impact of severe bacterial pneumonia and ALI/ARDS, novel therapies are needed to address this common and growing clinical problem.

Bone marrow derived mesenchymal stem cells (MSCs) are an emerging form of cell-based therapy that have been increasingly studied in experimental models of lung injury and sepsis. Experimental studies have shown that murine MSCs can improve survival, reduce lung injury, and enhance bacterial clearance in clinically relevant models of bacterial pneumonia in mice. These beneficial effects have also been achieved using human MSCs in an ex-vivo human lung model of ALI.

Naveen Gupta, MD, Assistant Professor of Molecular and Experimental Medicine and Principal Investigator at The Scripps Research Institute, has authored and co-authored a number of publications in peer-reviewed journals in this field. He commented that, “This project will investigate the therapeutic effects of Stemedica’s ischemia tolerant MSCs in experimental lung injury and sepsis. Specifically, it will determine the optimal route, dose and timing of cell delivery in an E. coli pneumonia model. In addition, studies will be done using purified soluble factors secreted by the stem cells to determine whether a therapeutic effect comparable to using live MSCs can be achieved.” Dr. Gupta continued: “Given Stemedica's expertise in the field of developing MSC-based clinical therapies and the scientific and clinical expertise in Pulmonary and Critical Care Medicine present at Scripps, I believe that this will be a mutually beneficial and productive collaboration that may have important implications in how cell based therapy is applied to critically ill patients.”

Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica noted, “One of the great advantages of using Stemedica’s cGMP produced, FDB licensed (Food & Drug Branch of the California Department of Public Health) stem cells is that they have already been approved by the Food and Drug Administration for use in a variety of clinical trials. The same cGMP manufactured cell can be used in all phases of the approval process from preclinical through clinical trials and ultimately to commercialization. This will contribute significantly to accelerating the process from benchtop to bedside.”

Maynard Howe, Ph.D., Vice Chairman and Chief Executive Officer of Stemedica commented, “We are pleased to be working with a renowned organization like Scripps to advance treatment for this critical condition. The goals of our organizations are aligned--we strive to save lives--and one of the most meaningful ways we can do this is to stem mortality from ARDS.”

About The Scripps Research Institute
The Scripps Research Institute is one of the world's largest independent, not-for-profit organizations focusing on research in the biomedical sciences. Over the past decades, TSRI has developed a lengthy track record of major contributions to science and health, including laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. The institute employs about 3,000 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists (including three Nobel laureates) work toward their next discoveries. The institute's graduate program, which awards Ph.D. degrees in biology and chemistry, ranks among the top ten of its kind in the nation. For more information, see http://www.scripps.edu.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke, acute myocardial infarction, and cutaneous photoaging. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

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